Focal One concentrates intense ultrasound energy on targeted cancerous lesions, effectively eliminating the majority of tumour cells within the gland while preserving healthy surrounding tissue. | Supply: EDAP
In earlier this year, EDAP TMS SA published the findings of a landmark HIFI study, which evaluated the efficacy and safety of high-intensity focused ultrasound (HIFU) therapy in treating patients with localized prostate cancer. The examination contrasts the French company’s robotic Focal One system with
These quality-of-life enhancements, such as reduced incidence of urinary incontinence or diminished erectile function, were the catalyst that led Ryan Rhodes to assume the role of CEO. Prior to that milestone, Rhodes dedicated more than 13 years of his professional life to… As a result, he observed that the impact of treating prostate cancer patients on Intuitive’s business was significant.
Within a year, he claimed, the company achieved profitability due to the surge in radical prostatectomy procedures performed using Intuitive’s pioneering Da Vinci system. Despite their potential benefits, every technological advancement, including robotics, carries inherent risks and dangers, according to Rhodes.
By around 2015, various discussions were underway regarding the potential overutilization of radical surgery for prostate disease treatment, despite the risk of undesirable side effects, noted Rhodes. “Now, we will risk-stratify patients more accurately, exploring options beyond radical surgery, such as Focal One – an innovative approach that leverages advanced imaging and incorporates biopsy data to enable surgeons to develop targeted plans for precise ablation.”
FocalOne offers a non-surgical alternative.
Focal One’s HIFU Robotic System leverages advanced imaging capabilities and proprietary HIFU technology, enabling urologists to precisely target the prostate with unparalleled submillimeter precision. The technology allows for the preservation of healthy, surrounding tissue, thereby safeguarding an individual’s overall well-being and maintaining a high quality of life, according to the company.
While surgeons may employ robotic assistance, the fundamental nature of their work remains a surgical procedure at its core. “Surgical procedures involve a range of intricate steps, including chopping, coagulating, suturing, score traction, and harm prevention, each playing a crucial role in the overall process.” “Our non-invasive approach eschews surgery, eliminating the need for blood loss, invasive cutting techniques, and radiation.”
As a result, the Focal One system enables minimally invasive surgeries to be performed without a doctor’s presence, potentially allowing for same-day or outpatient procedures. Hospitals equipped with a urologist, an anesthesiologist, and a nurse can efficiently perform HIFU procedures in a mere 40-to-60-minute timeframe, according to Dr. Rhodes. Will significantly reduce staff callouts for numerous hospitals already struggling to cope.
“That benefits everyone, and undoubtedly urologists acknowledge the financial gains,” said Rhodes. Since there’s no operative procedure involved, there’s no operative fatigue.
Physicians can leverage familiar imaging to guide ultrasound expertise, utilizing the same protocols employed during biopsies. Notably, many physicians have conducted biopsies on patients themselves, allowing them to recall specific areas of interest, cancer locations, and borders with ease.
Surgical procedures often present a complex puzzle to be solved, according to Rhodes. Physicians often enter surgical procedures without fully anticipating the complexities they may encounter. Focal One aims to eliminate uncertainty by leveraging a cutting-edge five-axis robotic system.
HIFI examine finds favorable outcomes
From April 2015 to March 2022, a seven-year period saw the enrollment of 3,328 participants across 46 therapy centers. Approximately 1,967 patients have received treatment using EDAP’s cutting-edge robotic high-intensity focused ultrasound (HIFU) technology in succession. The French Ministry of Health and Wellbeing funded the study with a grant of twenty million dollars.
Physicians employed Focal One in approximately 90 per cent of cases, with a total of 1,361 patients undergoing radical prostatectomy surgery. All patients have been followed for 30 months. The outcomes have been printed on the reports, which reveal significant improvements in productivity and efficiency.
By 30 months, the rate of treatment-free survival after adjusting for salvage treatments proved significantly higher in the HIFU group, with a remarkable 90% success rate, compared to 86% in the RP group. After controlling for multiple factors, including age, body mass index, American Society of Anesthesiologists rating, grade group, and prostate volume, the likelihood of salvage therapy was found to be lower in the high-intensity focused ultrasound (HIFU) arm compared to radical prostatectomy (RP).
The EDAP report indicated that this finding persisted in the subgroup characterised by an intermediate level of threat.
According to Rhodes, the HIFU treatment demonstrated a significant improvement in urinary continence among patients at the 12-month mark, outperforming surgical procedures. While results in the HIFU group surpassed baseline ratings for erectile function, patients undergoing surgery also achieved substantial improvements. The RP surgical procedure was often performed using robotics as well. While not exclusively focused on robotics, many patients have benefited from robotic surgery.
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“Accordingly, our innovative therapy approach utilizes robotic-focused HIFU treatment to preserve the prostate gland while selectively targeting and treating only the cancerous areas within it, leaving the healthy tissue intact.”
EDAP TMS has revealed its strategy to strengthen its foothold in the ultrasound market with the acquisition of Focal-One.
FocalOne has secured regulatory approval and is currently marketed in the United States, Europe, Canada, South Korea, Russia, and Brazil, among other countries. This latest examination expands access to the system in France.
According to Rhodes, the primary focus of the study is patient engagement. “Patients seek access to innovative technologies that address their condition and improve life’s overall quality.” What’s truly enriching is that this study gives us a unique vantage point to confront not only patients themselves, but also urologists treating prostate cancer patients, hospitals providing point-of-care services, and payers footing the bill for treatment.
Accordingly, EDAP is poised to leverage Focal One’s expertise in various procedures, the company’s CEO emphasized. The corporation is currently conducting a Phase 2 study across three European facilities to evaluate the efficacy of Focal One in managing benign prostatic hyperplasia (BPH).
As men age, this condition becomes increasingly prevalent; our research has shown that following treatment to ablate prostate tissue for cancer, patients experience a notable improvement in urinary symptom scores. So this reasoning will indeed make logical sense. When ablative procedures remove tissue and create a necrotic effect, they fundamentally alter the stress dynamic on the prostatic urethra.
As part of its efforts, EDAP is investigating the potential of Focal One in addressing deep infiltrating endometriosis cases.
“We’re discussing a rare case of endometrial implants that have infiltrated and migrated to the rectal wall,” explained Rhodes. So, these societal expectations and pressures create a multitude of problems, symptoms, and distress for many young girls. “We’ve developed an option for ablating endometrial implants using the same Focal One platform, guided by ultrasound steering.”
